Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 98-7079, Estradiolvalerate/ Dienogest/ Levomefolate calcium · 1 trial · 1 indication
Area under the concentration vs time curve from zero to infinity for DNG
Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
| Arm | Type | Description |
|---|---|---|
| Estradiol + dienogest + levomefolate | EXPERIMENTAL | Treatment A |
| Estradiol + dienogest | ACTIVE_COMPARATOR | Treatment B |
| Levomefolate | ACTIVE_COMPARATOR | Treatment C |
| Name | Type | Description |
|---|---|---|
| BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium | DRUG | Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days |
| BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) | DRUG | Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days |
| BAY 86-7660,levomefolate calcium | DRUG | Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days |
Inclusion Criteria: * Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women \<60 years old: follicle-stimulating hormone ≥ 40 IU/L at screenin...
BAY 98-7079 is an investigational small molecule combination of estradiol valerate, dienogest, and levomefolate calcium developed by Bayer AG. It has been studied in a Phase 1 bioequivalence trial in Germany. The combination pairs two hormonal components with levomefolate calcium, a folate form, and remains in clinical development.
BAY 98-7079 has been studied in a Phase 1 pharmacology and clinical bioequivalence trial, not in a patient treatment setting. The completed study enrolled healthy female volunteers aged 45 years and older in Germany. No approved indication has been established for this combination.
Bayer AG develops BAY 98-7079. Bayer trades on the OTC market under the ticker BAYRY. The company sponsored the Phase 1 bioequivalence study of the estradiol valerate, dienogest, and levomefolate calcium combination conducted in Germany.
BAY 98-7079 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication based on the available development record.
BAY 98-7079 has been evaluated in one completed Phase 1 trial, NCT00941057, titled a bioequivalence study of 2 mg estradiol valerate and 3 mg dienogest without and with levomefolate calcium. The randomized, active-controlled study enrolled 43 healthy female volunteers aged 45 years and older in Germany.